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Polyganics B.V.,

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K141816HEMOPOREOctober 23, 2014
K141423NASOPORE-FDAugust 7, 2014
K112267NEUROLAC(R) NERVE GUIDEOctober 20, 2011
K070715NASOPORE EARMay 7, 2007
K062540NASOPORE EAR, MODELS ND04, ND05October 18, 2006
K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZNovember 21, 2005
K050573NEUROLAC NERVE GUIDEMay 4, 2005
K042811VIVOSORB SHEET, MODEL FS01November 8, 2004
K032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03October 10, 2003